Sustained release treatment option could soon be available for diabetic patients in 28 countries of the European Union.
Marlow, UK, 24th July, 2014 – Allergan Ltd. announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended extending the Marketing Authorisation for OZURDEX® (dexamethasone 700mcg intravitreal implant in applicator) to treat adult patients with vision loss due to diabetic macular oedema (DME) who are pseudophakic (have an artificial lens implant), or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy. DME is a condition that affects approximately 7% of patients with diabetes1 and is the leading cause of sight loss in patients with diabetes.2 Uncontrolled diabetes can lead to inflammation and swelling in the part of the eye where focusing occurs (macula) causing blurred vision, vision loss and eventual blindness.3 Patients with DME may have other health issues which can result in the need for frequent visits to a wide range of healthcare professionals. Effective but less frequent treatments for DME could be advantageous for patients, their caregivers and the healthcare system.
“With a commitment to the development of innovative treatment options that address unmet patient needs, we are pleased with the CHMP’s recommendation to expand the license for OZURDEX® , an important tool in the armamentarium of the European retinal specialist, as evidenced by the fact that OZURDEX® sales are currently more than twice those of the United States,” said David E.I. Pyott, Allergan’s Chairman of the Board and Chief Executive Officer. “Allergan is widely recognized for having one of the most productive R&D pipelines in the industry and secured a record 180-plus approvals for products and indications around the world last year. Our ability to advance R&D programs allows us to continually bring forth new treatment options for physicians and their patients while delivering value to our stockholders.”
The safety and efficacy of OZURDEX® in the management of patients with diabetic macular oedema was assessed in Allergan’s MEAD phase III studies.4 These were 3-year, multi-centre, double-masked, controlled clinical studies in which 1048 patients were randomized to receive either OZURDEX® 350mcg or 700mcg, or sham (simulated) injections. The results from the studies showed that:
- The percentage of patients with a 15 or more letter gain was significantly greater in those treated with OZURDEX® than sham, at 3 years.4
- Meaningful treatment benefit was observed with a mean of only 4 to 5 injections over 3 years. 4
- Treatment with OZURDEX® was generally well-tolerated with manageable adverse effects. OZURDEX® demonstrated good systemic safety. Common adverse events included elevated intraocular pressure and cataract, although there were no unexpected adverse events. 4
“OZURDEX® is a leading treatment for macular edema in patients with retinal vein occlusion and uveitis in Europe, and is approved for multiple indications in the United States including most recently for use in certain patients with diabetic macular edema,” said Scott M. Whitcup, M.D., Allergan’s Executive Vice President, Research and Development, Chief Scientific Officer. “DME is a complicated disease to treat, and the additional license for OZURDEX® in the EU would offer another important treatment option to help preserve vision for patients.”
The Committee for Medicinal Products for Human Use (CHMP) is the scientific committee of the European Medicines Agency (EMA) that recommends medicines for Marketing Authorization across the 28 member states of the European Union. The decision from the European Commission is expected within a few months. If approved, Allergan anticipate launching this new indication to physicians as soon as possible across the region. OZURDEX® (dexamethasone 700mcg intravitreal implant in applicator) is already available in Europe as a treatment licensed for macular oedema in patients with retinal vein occlusion (RVO) and for inflammation of the posterior segment of the eye characterized as non-infectious uveitis.5
1. Yau JWY et al. Global Prevalence and Major Risk Factors of Diabetic Retinopathy Diabetes Care 2012;35: 556-564
2. Romero-Aroca P. Managing diabetic macular edema: The leading cause of diabetes blindness. World J Diabetes 2011; 2(6): 98-104
3. Chen E et al. Burden of illness on diabetic macular edema: literature review. Curr Med Res Opin. 2010;26:1587-1597
4. Boyer DS et al. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthal 2014: 1-11 Epub ahead of print
5. OZURDEX® Summary of Product Characteristics (www.medicines.org.uk)
6. Obrosova IG et al. Diabetic cataracts: mechanisms and management Diabetes Metab Res Rev 2010;26: 172-180
7. Ciulla TA et al. Diabetic Retinopathy and Diabetic Macular Edema Diabetes Care 2003;26: 2653-2664
8. Klein R et al. The Wisconsin epidemiologic study of diabetic retinopathy XV. The long-term incidence of macular edema. Ophthalmology 1995;102:7–16.
9. International Diabetes Federation (IDF). IDF Diabetes Atlas – 2013;Sixth Edition: 1-160
10. Allergan data on file – EU5 Retina Market; created 24 July 2014
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This press release contains “forward-looking statements”, including the statements by Mr. David Pyott, Dr Scott Whitcup and other statements regarding research and development outcomes, efficacy, adverse reactions, potential for the European Commission granting final Marketing Authorization, market and product potential, product availability and other statements regarding OZURDEX® for the treatment of diabetic macular oedema. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan’s expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; challenges related to achieving regulatory approval from the European Commission on a timely and cost-efficient manner; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risks can be found in press releases issued by Allergan, as well as Allergan’s public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading “Risk Factors” in Allergan’s Form 10-K and subsequent Quarterly Reports on Form 10-Q.